APPLICATION
ANDA203895
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-05
LATEST ACTION
2023-08-02
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, RETROBULBAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
BUPIVACAINE HYDROCHLORIDE 0.25% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
Approval history
2023-08-02Labeling · Supplement 10 · standardAP
2023-03-10Labeling · Supplement 8 · standardAP
2019-07-09Labeling · Supplement 2 · standardAP
2013-11-05UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.